PeriView FLEX
Bronchoscope Accessory
Olympus Surgical Technologies America
The following data is part of a premarket notification filed by Olympus Surgical Technologies America with the FDA for Periview Flex.
Pre-market Notification Details
| Device ID | K181193 |
| 510k Number | K181193 |
| Device Name: | PeriView FLEX |
| Classification | Bronchoscope Accessory |
| Applicant | Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Contact | Mary Anne Patella |
| Correspondent | Mary Anne Patella Olympus Surgical Technologies America 136 Turnpike Road Southborough, MA 01772 -2104 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-04 |
| Decision Date | 2018-07-03 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925042506 | K181193 | 000 |
Trademark Results [PeriView FLEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERIVIEW FLEX 87419294 5532874 Live/Registered |
Olympus Corporation 2017-04-20 |
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